HELP Committee also advances Hickenlooper’s Early Hearing Detection and Intervention Act
Washington, D.C. – Today the U.S. Senate Committee on Health, Education, Labor and Pensions voted to pass several provisions led by U.S. Senator John Hickenlooper to make drug pricing more competitive and improve transparency at the Food and Drug Administration (FDA). The Hickenlooper provisions passed as part of the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act, which reauthorizes the FDA’s user fee programs for five years.
The bipartisan bill takes steps to lower prescription drug costs for consumers, including bipartisan drug importation provisions to make it easier for more Americans to safely import drugs from Canada.
“American pioneering has developed countless medical treatments, but we have some of the highest prices for prescription drugs in the world,” said Hickenlooper. “This bill will improve competition and lower costs for consumers.”
Hickenlooper led several provisions that were added to the FDA bill, including:
- Transparent Accelerated Approval: Hickenlooper’s bill to improve transparency and public trust in FDA drug approvals by requiring the FDA to publicly release a summary of their reasoning for approving drugs and other therapies via the Accelerated Approval process. This would address a lack of transparency in approvals such as Biogen’s Aduhelm drug to treat Alzheimer’s.
- Increasing Generic Competition: Hickenlooper and Senator Mitt Romney’s Enhanced Access to Affordable Medicines Act, which will speed FDA approval for generic drugs – increasing competition and lowering prices for consumers.
- Streamlining Medical Device Updates: Hickenlooper and Senator Mike Braun’s amendment to speed approval for updates to medical devices by expanding the FDA’s Predetermined Change Control Plan policy, which currently only applies to AI software.
- Addressing Infant Formula Shortage: Provisions modeled off of Hickenlooper’s bill with Senator Bob Casey to require infant formula manufacturers to notify the FDA of potential supply chain disruptions and empower FDA to help prevent and mitigate shortages.
The Committee also voted to pass Hickenlooper’s Early Hearing Detection and Intervention Act of 2022, which reauthorizes current research and improves public health programs for early detection, diagnosis, and treatment of hearing loss in newborns, infants, and young children for five additional years.